Senior Engineer , MSEO Automation and Data Analytics

Shift Available:

- Monday–Friday 9:00am–5:00pm

• Act as SME in data analytics; partner with Manufacturing/Technical to define, prioritize, document business needs, and deliver data analytics/data science solutions (key conduit between business and BI&T).
• Build dashboards/visualizations; perform ad-hoc data analysis for operational/business decisions.
• Provide technical direction to site teams to improve capacity, quality, cost, and root cause.
• Establish and maintain service level expectations across functions and site systems.
• Support automation/data intake assessment and backlog; ensure alignment with site objectives and senior leadership direction.
• Deliver network improvements (recipe updates, manufacturing data analysis, MES product impact assessments).
• Develop/configure digital solutions (e.g., electronic batch records, process automation) across the solution lifecycle.
• Support lifecycle management, incident/quality investigations, CPV/process monitoring, automated system lifecycle/improvements, and cross-functional interfacing.
• Lead QMS deliverables (SOPs/work practices/training/Change Controls/Actions/CAPAs/technical reports) and drive change management/process improvement.

• Leadership/mentoring; critical reasoning/decision-making; strong organization/time management; independent and cross-functional teamwork.
• Strong written/verbal communication; advanced MS Office;
  Tableau/Power BI reporting.
• cGMP and multinational biopharmaceutical regulations; cell therapy experience preferred.
• Preferred: ERP/PCS/MES understanding; E /RBE and MES recipe lifecycle; HP ALM/EDMS/change systems; CAR-T/biopharma manufacturing & QC; cell culture/cryopreservation/aseptic processing; manufacturing boundary systems.
• Preferred: SQL and Python (or R) data science packages.
• Ability to travel 10%–15%.

• Bachelor’s degree (Engineering, Biological/Life Sciences, Chemistry, Biochemistry, or related) or equivalent.
• 6+ years manufacturing support/engineering (biotech/pharma).
• 2+ years leadership/supervisory experience preferred.

• Summit West (NJ, US): $106,810–$129,430; additional incentive opportunities may be available.
• Health coverage; wellbeing programs; 401(k), disability, life insurance and other listed protection benefits;
  Paid Time Off (flexible time off or vacation/holidays depending on location).